1 may 2010 © 2002-2010 health level seven international®, inc. all rights reserved. hl7 and health...
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11May 2010
© 2002-2010 Health Level Seven International®, Inc. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International, Inc. Reg. U.S. Pat & TM Off
EFMI STC 2010
John QuinnHL7 CTO
HL7 Electronic Health Record System (EHR-S) Functional Model and Standard and Personal Health Record System (PHR-S) Functional Model
22May 2010
© 2002-2010 Health Level Seven International®, Inc. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International, Inc. Reg. U.S. Pat & TM Off
EHR vs. EHR-S
EHRThe underlying single, logical patient recordThe data elements comprising the recordServing as the legal record
EHR-SSoftware that provides functionality to:
Manage and maintain the health record Accomplish various clinical, research, and business
purposes of the health record
May be monolithic system or system of systems
33May 2010
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PHR - EHR: What Are the Differences?
EHRProvider or Health Service controlledBusiness, operations and legal recordCaptures clinical, administrative, financial data
PHRTypically controlled/managed by patient or their
representativeCaptures patient’s health/healthcare info across
multiple providers and includes self-entered dataNot a legal record
44May 2010
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How It Started - Request from US Govt
May, 2003: US Centers for Medicare and Medicaid Services askedUS Institute of Medicine for guidance on care
delivery functions IOM & HL7 to coordinate development of a
functional model for an EHR system, not transaction-oriented interchanges
Needed as basis for pay for performance
55May 2010
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From DSTU to HL7 Standard
Approved July 2004 as a draft standard for trial use (DSTU)2 year period to continuously improve DSTU,
become an HL7 standardCore, not exhaustive, functionalityGood enough for industry to begin using as a
standard
Approved February 2007 as full normative HL7 standard
66May 2010
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The EHR-S Functional Model
Is Not… A messaging specification An EHR record specification An implementation
specification (what, why, not how) Does not prescribe
technology Does not dictate how
functions must be implemented (e.g., user interface, database design)
Is… An EHR system specification A reference list of functions
that may be present in an EHR-S (the “what”) Enables consistent
expression of functionality Provides flexibility for
innovation and product differentiation
Gold standard, sensitive to what can practically be done by a system, future system development
77May 2010
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Functions describe the behavior of an EHR
system in user-oriented language
EHR-S Functional Model at a Glance
88May 2010
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EHR-S Functional Model & Standard
Function names & statements provide a reference list of functions that:May be present in an EHR-SAre understandable from a user’s perspectiveEnable consistent expression of functionality
Conformance criteriaRequired/mandatory: The system SHALL…Preferred: The system SHOULD…Optional: The system MAY…
99May 2010
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The Structure of the Functional Model
DC.1.1.1 F Identify and Maintain a Patient Record
Statement: Identify and maintain a single patient record for each patient.Description: A single record is needed for legal purposes, as well as to organize it unambiguously for the provider. Health information is captured and linked to the patient record. Static data elements as well as data elements that will change over time are maintained. The patient is uniquely identified, after which the record is tied to that patient. Combining information on the same patient, or separating information where it was inadvertently captured for the wrong patient, helps maintain health information for a single patient. In the process of creating a patient record, it is at times advantageous to replicate identical information across multiple records, so that such data does not have to be re-entered. For example, when a parent registers children as new patients, the address, guarantor, and insurance data may be propagated in the children’s records without having to re-enter them.
S.1.4.1S.2.2.1S.3.1.2S.3.1.5IN.2.1IN.2.3
1.The system SHALL create a single logical record for each patient.
1.The system SHALL provide the ability to create a record for a patient when the identity of the patient is unknown.
1.The system SHALL provide the ability to store more than one identifier for each patient record.
1.The system SHALL associate key identifier information (e.g., system ID, medical record number) with each patient record.
1.The system SHALL provide the ability to uniquely identify a patient and tie the record to a single patient.
1.The system SHALL provide the ability, through a controlled method, to merge or link dispersed information for an individual patient upon recognizing the identity of the patient.
1.IF health information has been mistakenly associated with a patient, THEN the system SHALL provide the ability to mark the information as erroneous in the record of the patient in which it was mistakenly associated and represent that information as erroneous in all outputs containing that information.
1.IF health information has been mistakenly associated with a patient, THEN the system SHALL provide the ability to associate it with the correct patient.
1.The system SHALL provide the ability to retrieve parts of a patient record using a primary identifier, secondary identifiers, or other information which are not identifiers, but could be used to help identify the patient.
ID#Type Name Statement/Description See Also Conformance Criteria
1010May 2010
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OutpatientInpatient Home
EHR-S Functions
Wellness Reminders
Medication Administration Record
Bed management
Lifestyle
Medication Admin Record
Order Management Order Management Order Management
Notes Notes Notes Notes Notes Notes
Results Reporting Results Reporting Results Reporting
Drug-Drug Interaction Drug-Drug Interaction Drug-Drug Interaction
Demographic Management Demographic Management
Security Security Security Security Security Security Security Security
Record Management Record Management Record Management
Wellness Reminders
Event Capture Event Capture Event Capture Event Capture
Profiles Can Be Derived from the FM
1111May 2010
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Profiles Developed/Under Development
Ambulatory Care Ambulatory Oncology Behavioral Health Child Health Clinical Research, Clinical Trials Dentistry ePrescribing/Pharmacy Emergency Department Long Term Care Public Health Records Management & Evidentiary Support Vital Records, Statistics Reporting Also: Canadian EHR Blueprint 2015 (Infoway Project)
1313May 2010
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Definitions: Fitting it all together
Standard Conformance clause, conformance criteria
Conformance TestingTest suite, Test tool
(test software, test scripts, test criteria)
Validation Process - policy and procedures for testing
Certificationqualified bodies to do the testing and certification
control board - advisory and arbiter
ProfileWe areconcerned
with
1515May 2010
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Current Activities
Additional profiles under development Including realm (country)-based profiles
Release 2 under development ISO/HL7 Joint Ballot (ISO 10781)
Personal Health Record System FM DSTU, Release 1 normative under development Also planned as ISO/HL7 Joint Ballot
Incorporate HL7 EHR Interoperability and EHR Lifecycle Model DSTUs
1616May 2010
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Status of PHR-S FMDraft Standard for Trial Use Ballot
The PHR-System Functional Model: Balloted in November 2007 Reconciliation Complete in March 2008 Published as DSTU in July 2008 Lists the functions that PHR systems shall, should
or may perform Provides support for a certification framework Serves as an anchor point for PHR system
interoperability
1717May 2010
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Status of the International Standard
HL7 has built on its solid foundation of international healthcare information technology standards by promoting the Electronic Health Record System Functional Model (EHR-S FM) to an ISO standard for Electronic Health Record System functionality ISO 10781, published November 2009
1818May 2010
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Status of the International Standard
On May 11, 2010 ISO TC215 WG8 approved both NWIPs for HL7 EHR/PHR System Functional Models. This was followed by a formal resolution approval by the full TC215 Plenary Meeting on Thursday May 13.
The May 11 vote was unanimous (without abstention) on both NWIPs - comprising ~50 international experts.
1919May 2010
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Status of the International Standard
On Thursday, 13 May, ISO TC215 approved the Release 2 update to ISO 10781/HL7 EHR System Functional Model as a preliminary work item. HL7 plans to submit documents to the TC215 Secretariat by 10 June and expect the formal New Work Item Proposal to go to ballot by 1 July 2010. If all goes according to schedule the ballot will close prior to October when HL7 and ISO meetings (in Cambridge, MA and Rotterdam respectively) occur. This item is being promoted through the ISO/HL7 Pilot Agreement as an International Standard and will be jointly balloted by ISO and HL7.